Status: Published. Publication date: Edition: 1. Number of pages: 4. Technical Committee.: ISO/TC Sterilization of health care products. ICS. ISO INTERNATIONAL. STANDARD. ISO. First edition. Sterilization of health care products —. Ethylene oxide —. Part 1. Permission can be requested from either ISO at the address below or ISO’s ISO cancels and replaces ISO and.
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Overview Product Details What is this standard about? Why should you use this standard? Medical equipment, Sterilization hygieneEthylene oxide, Hygiene, Medical instruments, Sterile equipment, Performance, Performance testing, Quality control, Maintenance, Acceptance approvalVerification, Microbiological analysis, Instructions for use, Personnel, Sterilizers, Management. It describes requirements that, if met, will provide an ethylene oxide sterilization process with appropriate microbiocidal activity intended to sterilize medical devices.
Worldwide Standards We can source any standard from anywhere in the world. This international standard sets out how to ensure that medical devices are sterilized effectively using an ethylene oxide sterilization process.
Who is this standard for?
BS EN ISO 11135:2014
Requirements for the development, validation and routine control of a sterilization process for medical devices Status: Learn more about the cookies we use and how to change your settings. Take the smart route to manage medical device compliance.
Anyone responsible for sterilizing medical devices in both industrial and health care settings. Search all products by.
ISO /Amd – Revision of Annex E, Single batch release
It tackles the need for quality systems, staff training and proper safety measures and covers the following points: Accept and continue Learn more about the cookies we use and how to change your settings.
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Requirements for the development, validation and routine control of a sterilization process for medical devices. Symbols to be used with medical device labels, labelling and information to be supplied General requirements.
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